A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
Completed · Phase 3
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
To compare the safety and effectiveness of drug therapy with aerosolized pentamidine (PEN) with that of conventional therapy, sulfamethoxazole plus trimethoprim (SMX/TMP) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection. New treatments are needed for PCP, a common lung infection in patients with AIDS, because many patients treated with the two standard treatments, PEN given by injections and SMX/TMP, have had adverse effects that required a change in treatment. There is also a high relapse rate after the standard treatments. Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse effects.
Key facts
- Study ID
- NCT00000715
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 240
- Expected to finish
- 1991-09-01
- Last updated by the study team
- 2021-11-03
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior Medication:
- Allowed:
- Zidovudine (AZT), but must be suspended during study medication.
- Unequivocal diagnosis of Pneumocystis carinii pneumonia established by morphologic confirmation of three or more typical Pneumocystis carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 5 days of randomization, the patient will be withdrawn from study therapy. Resting (A-a) DO2 less than 30 torr on room air at all ACTG sites except San Francisco General Hospital. Non-ACTG sites will enter patients up to a resting (A-a) DO2less than 55 mmHg on room air.
You may not qualify if…
- Co-existing Condition:
- Patients with the following are excluded:
- Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration.
- History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as:
- Absolute neutropenia of 750 or less PMN + bands cells/mm3.
- Thrombocytopenia below 40000 platelets/mm3.
- Rise in creatinine:
- To more than 3.0 mg/dl.
- Liver function abnormalities:
- SGOT or SGPT greater than 5 x upper limit of normal.
- Hypoglycemia below 50 mg/dl.
- Rash:
- Exfoliative or mucositis.
- Cough:
- Unremitting or bronchospasm uncontrolled by bronchodilator preventing more than 50 percent of delivered dose for more than 2 days.
- Concurrent Medication:
- Excluded:
- Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia.
- Zidovudine (AZT).
- Patients with the following are excluded:
- Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration.
- History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as:
- Absolute neutropenia of 750 or less PMN + bands cells/mm3.
- Thrombocytopenia lower than 40000 platelets/mm3.
- Rise in creatinine:
Where it is running
- Tulane Univ School of Medicine — New Orleans, Louisiana, United States
- Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
- Mount Sinai Med Ctr — New York, New York, United States
- Univ of Rochester Medical Center — Rochester, New York, United States
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States
- Univ of North Carolina — Chapel Hill, North Carolina, United States
- Holmes Hosp / Univ of Cincinnati Med Ctr — Cincinnati, Ohio, United States
- Univ Hosp of Cleveland / Case Western Reserve Univ — Cleveland, Ohio, United States
- Julio Arroyo — West Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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